Apparatus and methods for capsule endoscopy of the esophagus

ABSTRACT

Apparatus and methods for capsule endoscopy are described for locating, positioning, steering, aiming and tracking of an endoscopy capsule within a patient&#39;s esophagus and stomach. The apparatus includes an endoscopy capsule with a magnetic element an external capsule positioning system including at least one magnet movable along a track for positioning the endoscopy capsule within a patient. Also described are apparatus and methods for performing endoscopic spectroscopy using different wavelengths of light and other imaging technologies to diagnose various disease conditions, such as premalignant or inflammatory changes and internal bleeding.

FIELD OF THE INVENTION

The present invention relates generally to apparatus and methods for performing capsule endoscopy. More specifically, it relates to apparatus and methods for locating, positioning, steering, aiming and tracking of an endoscopy capsule within a patient's esophagus and stomach. It also relates to apparatus and methods for performing endoscopic spectroscopy using different wavelengths of light and other imaging technologies to diagnose various disease conditions, such as premalignant or inflammatory changes, as well as internal bleeding.

BACKGROUND OF THE INVENTION

Capsule endoscopy is a method of examining the interior of a patient's gastrointestinal tract using an endoscopy capsule or “camera pill” that includes a miniaturized camera and a light source inside an ingestible capsule. Typically, the patient swallows the endoscopy capsule, which takes a series of pictures as it passes through the patient's digestive system and transmits the images to a receiver external to the patient. The endoscopy capsule passes out of the digestive system in the patient's stool and is discarded. Capsule endoscopy has proven to be most valuable in examining and diagnosing a patient's small intestine, as this portion of the gastrointestinal tract is not readily accessible using standard flexible endoscopy methods.

Recent studies have investigated the use of capsule endoscopy for examination of a patient's esophagus, particularly for diagnosing Barrett's esophagus, a precancerous condition associated with chronic gastroesophageal reflux disease (GERD). Success of these studies has been hampered in part by the fast transit time of the endoscopy capsule through the esophagus (typically 1-8 seconds), as compared to other portions of the gastrointestinal tract. The rapid transit time allows only a few images to be taken of the esophagus (typically 4-11 images) and many times the area of greatest interest at the gastroesophageal junction or “Z-line” is missed entirely. Efforts to improve the effectiveness of capsule endoscopy of the esophagus have included having the patients examined in a supine position to slow down the transit time of the capsule through the esophagus, taking more images per minute, and having patients swallow a capsule with a string attached to it to retard the passage of the capsule through the esophagus. However, these measures have not proven to be entirely effective. Even the most successful studies to date have had results that would make esophageal capsule endoscopy appropriate only as a screening tool and not as an accurate diagnostic technique.

Systems have been proposed for stereotactic positioning or steering of instruments, such as needles, catheters and endoscopy capsules, within a patient's body using externally applied magnetic fields. These systems are generally very complex and expensive, and it would be cost-prohibitive to use these systems for all routine esophageal capsule endoscopy examinations.

What is needed and has not been available heretofore is an effective and cost-efficient means for locating, positioning, steering and tracking of an endoscopy capsule within a patient's esophagus. The following medical articles, patents and patent applications, which describe various aspects of capsule endoscopy and related technologies, are hereby incorporated by reference.

Capsule endoscopy of the esophagus?; A Nemeth, I Racz; 1st Department of Internal Medicine, Petz Aladar County and Teaching Hospital, Gyor; Zeitschrift fair Gastroenterologie; DOI: 10.1055/S-2004-827003 lecture

Capsule endoscopy: Can it replace upper endoscopy to screen for Barrett's esophagus?; F. Schnoll-Sussman, A. Hernandez, M. Bigg; 2004 Gastrointestinal Cancers Symposium; SubCategory: Upper GI Cancer (Esophageal and Gastric); Abstract No: 43

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EP1159917A1 Apparatus for measuring electrical characteristics of tissue

AU0160578A5 DEVICE AND METHOD FOR POSITIONING AN OBJECT IN A BODY LUMEN WO200189596A3 DEVICE FOR POSITIONING OBJECT IN A BODY LUMEN WO200189596A2 DEVICE AND METHOD FOR POSITIONING AN OBJECT IN A BODY LUMEN AU0156640A5 SYSTEM FOR CONTROLLING IN VIVO CAMERA CAPTURE AND DISPLAY RATE WO200187377A3 SYSTEM FOR CONTROLLING IN VIVO CAMERA CAPTURE AND DISPLAY RATE WO200187377A2 SYSTEM FOR CONTROLLING IN VIVO CAMERA CAPTURE AND DISPLAY RATE WO200169212A1 DEVICE AND METHOD FOR IN VITRO DETECTION OF BLOOD EP1039830A4 ENERGY MANAGEMENT OF A VIDEO CAPSULE AU0141004A5 A DEVICE AND SYSTEM FOR IN VIVO IMAGING WO200165995A3 A DEVICE AND SYSTEM FOR IN VIVO IMAGING WO200165995A2 A DEVICE AND SYSTEM FOR IN VIVO IMAGING EP1123035A1 A METHOD FOR DELIVERING A DEVICE TO A TARGET LOCATION WO200153792A3 A SYSTEM FOR DETECTING SUBSTANCES WO200153792A2 A SYSTEM FOR DETECTING SUBSTANCES EP1117323A1 A METHOD FOR TEMPERATURE SENSING AU0114097A5 METHOD FOR ACTIVATING AN IMAGE COLLECTING PROCESS WO200135813A1 METHOD FOR ACTIVATING AN IMAGE COLLECTING PROCESS IL0132944A0 METHOD FOR ACTIVATING AN IMAGE COLLECTING PROCESS AU0064656A5 A METHOD FOR TEMPERATURE SENSING WO200110291 A1 A METHOD FOR TEMPERATURE SENSING IL0131242A0 A METHOD FOR TEMPERATURE SENSING AU0052441A5 AN OPTICAL SYSTEM WO200076391A1 AN OPTICAL SYSTEM IL0110475A1 OPTICAL SYSTEM FOR FLEXIBLE TUBES EP1041919A2 SYSTEM AND METHOD FOR IN VIVO DELIVERY OF AUTONOMOUS CAPSULE EP1039830A1 ENERGY MANAGEMENT OF A VIDEO CAPSULE IL0130486A0 AN OPTICAL SYSTEM AU6364599A1 A METHOD FOR DELIVERING A DEVICE TO A TARGET LOCATION WO200022975A1 A METHOD FOR DELIVERING A DEVICE TO A TARGET LOCATION CA2347274AA A METHOD FOR DELIVERING A DEVICE TO A TARGET LOCATION IL0108352A1 IN VIVO VIDEO CAMERA SYSTEM WO199932028A3 SYSTEM AND METHOD FOR IN VIVO DELIVERY OF AUTONOMOUS CAPSULE IL0126727A0 A METHOD FOR DELIVERING A DEVICE TO A TARGET LOCATION AU1575899A1 SYSTEM AND METHOD FOR IN VIVO DELIVERY OF AUTONOMOUS CAPSULE AU1574599A1 ENERGY MANAGEMENT OF A VIDEO CAPSULE WO199932028A2 SYSTEM AND METHOD FOR IN VIVO DELIVERY OF AUTONOMOUS CAPSULE CA2315727AA SYSTEM AND METHOD FOR IN VIVO DELIVERY OF AUTONOMOUS CAPSULE WO199930610A1 ENERGY MANAGEMENT OF A VIDEO CAPSULE CA2314104AA ENERGY MANAGEMENT OF A VIDEO CAPSULE

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Capsule endoscopy is also used for imaging of the small intestine, especially to look for bleeding and inflammatory bowel disease. Currently available imaging capsules, as described in the publications listed above, use only the visible spectrum of light and the images are seen as regular images.

Endoscopic spectroscopy is an emerging technology for diagnosis of cancer and other diseases within a patient's body. Spectroscopic examination can be used to identify lesions that are not readily visible using white light endoscopy and/or to diagnose or differentiate tissues of suspected lesions that are found using white light endoscopy or other techniques. Auto fluorescence is a spectroscopic technique that illuminates a patient's tissues with one or more excitation frequencies and measures and/or images the natural fluorescence of the tissues.

Differences in the natural fluorescence can be used to distinguish between normal cells and certain types of diseased cells. Dye-enhanced fluorescence is a spectroscopic technique in which one or more special fluorescent marker dyes are applied to the tissues either topically or systemically. The tissues are then illuminated with one or more excitation frequencies and the fluorescence of the tissues is measured and/or imaged. Differences in the uptake of the fluorescent marker dyes can be used to identify lesions and/or to distinguish between normal cells and certain types of diseased cells. Other known spectroscopic techniques can also be used. The following U.S. patents and patent applications, each of which is incorporated herein by reference in its entirety, describe various spectroscopic techniques that can also be used in connection with the present invention:

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BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A and IB show a first embodiment of the apparatus of the invention, which includes an ingestible endoscopy capsule and an external capsule positioning system, in use for performing esophageal capsule endoscopy on a patient.

FIGS. 2A and 2B show a second embodiment of the apparatus of the invention in use for performing esophageal capsule endoscopy on a patient.

FIGS. 3A and 3B show a third embodiment of the apparatus of the invention in use for performing esophageal capsule endoscopy on a patient.

FIG. 4 is a schematic diagram of a synchronous drive mechanism for use in the apparatus of FIGS. 3A and 3B.

FIG. 5 shows an endoscopy capsule for use in the invention.

FIG. 6 shows an endoscopy capsule configured with two cameras.

FIG. 7 shows a spherical endoscopy capsule with a spherical imaging system.

FIGS. 8A and 8B show a spherical endoscopy capsule with two cameras.

FIG. 9 shows a spherical endoscopy capsule with a rotatable inner capsule.

FIG. 10 shows an endoscopy capsule with a selectively inflatable bladder.

FIG. 11 shows an endoscopy capsule with an asymmetric selectively inflatable bladder.

FIG. 12 shows an endoscopy capsule with a selectively expandable structure.

FIG. 13 shows a magnetic probe in the shape of a tongue depressor for retrieving the esophageal capsule after use.

FIG. 14 illustrates a video endoscope with an imaging capsule mounted on the distal end for visible light and/or spectroscopic imaging.

FIGS. 15A and 15B illustrate anterior and posterior views of another embodiment of an external capsule positioning system for use in performing esophageal capsule endoscopy on a patient.

FIGS. 16A and 16B illustrate anterior and posterior views of another embodiment of an external capsule positioning system for use in performing esophageal capsule endoscopy on a patient.

DETAILED DESCRIPTION OF THE INVENTION

FIGS. 1A and IB show a first embodiment of the apparatus of the invention in use for performing esophageal capsule endoscopy on a patient. The apparatus includes an ingestible endoscopy capsule 100 and an external capsule positioning system 200. The endoscopy capsule 100, which will be described in greater detail below, includes a magnetically attracted element, which may be a permanent magnet, an electromagnet or a magnetically attracted ferritic material. The external capsule positioning system 200 includes at least one external magnet 202, which may be a permanent magnet or an electromagnet, and means for positioning the external magnet 202 with respect to the patient's anatomy.

In one particularly preferred embodiment, the means for positioning the external magnet 202 includes a track 204, which is configured to be positioned over the esophagus on the ventral or anterior surface of the patient's torso. The track 204 is approximately linear when viewed from the anterior of the patient, as shown in FIG. 1A. Alternatively, the track 204 may be made in a curved configuration to accommodate patients whose esophagus cannot be approximated with a linear track. Viewed from the side, as in FIG. IB, the track 204 may be straight or curved and it may be rigid or flexible to conform to the curvature of the patient's torso. The track 204 is preferably long enough to extend at least from the patient's epiglottis to the stomach. The external magnet 202 can be moved up and down the track 204 manually or the movement of the external magnet 202 may be motorized. An alternative configuration of the positioning system 200 could use a continuous loop cable or drive belt or other linear actuator in place of the linear track 204 for moving the external magnet 202 up and down the patient's torso over the esophagus.

Preferably, the positioning system 200 includes means for fastening the track 204 to the patient's torso in a desired position over the esophagus. For example, the positioning system 200 may include a collar 206 and a waist belt 208 for fastening the track 204 to the patient, as shown in FIGS. 1A and 1B. Alternatively, the track 204 could be attached to a garment that is then fastened to the patient. The garment could be in the shape of a vest, apron or poncho. Alternatively, the track 204 could be attached to the patient in the correct position using adhesive tape or the like.

The positioning system 200 may include a position sensor for sensing the position of the external magnet 202 along the track 204, which will correlate with the position of the endoscopy capsule 100 within the esophagus. The position information can be collected and correlated with the images taken by the endoscopy capsule 100 so that the location of any suspicious lesions can be accurately pinpointed for further diagnostic tests, biopsy or treatment. In addition, the position information can be used by a computer to construct an accurate three-dimensional image or mathematical model of the esophagus from the images collected.

In use, the external capsule positioning system 200 is fastened to the patient, with the track 204 positioned over the esophagus. The external magnet 202 is positioned near the top of the patient's esophagus. If the external magnet 202 is an electromagnet, it should be energized at this time.

The patient is then asked to swallow the endoscopy capsule 100, which moves into the esophagus, but stays at the top of the esophagus and does not descend because it is attracted to the external magnet 202. The system may include a sensor to detect when the endoscopy capsule 100 is captured and held by the external magnet 202. Optionally, a light or other indicator will show when the endoscopy capsule 100 is captured and held by the external magnet 202. The external magnet 202 is moved downward slowly so that the endoscopy capsule 100 can capture a sufficient number of images, either still images and/or video images, to make a reliable diagnosis. If the physician wants to examine any particular area more closely, the movement of the endoscopy capsule 100 can be stopped or even reversed. The external magnet 202 can be moved up and down the track 204 manually or the movement of the external magnet 202 may be motorized.

The images can be transmitted by the endoscopy capsule 100 to an external receiver (not shown) and/or they can be stored in an electronic memory within the endoscopy capsule 100.

Generally, the examination continues until the endoscopy capsule 100′ reaches the gastroesophageal junction or “Z-line”, which is of particular interest in diagnosing Barrett's esophagus. Multiple images can be made of this area by slowing or stopping the descent of the endoscopy capsule 100′. In cases where the physician wishes to have a controlled examination of the stomach, the procedure can be continued into the stomach using the endoscopy capsule 100 and the external magnet 202 for guidance.

Once the esophageal examination is complete, the endoscopy capsule 100′ can be released so that it will travel through the rest of the patient's digestive system. This is done by lifting the external magnet 202′ or turning it off if an electromagnet is used. If desired, the endoscopy capsule 100′ 30 can be used to examine the rest of the patient's digestive system as it passes through.

Alternatively, the endoscopy capsule 100 can be retrieved by moving the external magnet 202 to the top of the track 204. Then a magnetic probe 300, which may be in the shape of a tongue depressor as shown in FIG. 13, is inserted through the patient's mouth. The endoscopy capsule 100 is released by lifting the external magnet 202, or turning it off if an electromagnet is used, so that the magnetic probe 300 can capture and retrieve the endoscopy capsule 100. The magnet 302 in the magnetic probe 300 can be a permanent magnet or an electromagnet.

Retrieving the endoscopy capsule 100 in this manner is especially useful when the capsule is used for taking biopsy samples or the like because it is quicker, more convenient and more certain than collecting the capsule from the patient's stool. Laboratory results will not be delayed by the transit time of the capsule through the intestines. It also eliminates the possibility that a biopsy device in the capsule would contaminate the rest of the digestive tract with malignant cells or other hazardous material.

An optional accessory to the endoscopic imaging system, which could be used in combination with or separately from the external positioning system 200, is a device in the form of a collar or necklace with a permanent magnet or electromagnet for holding the imaging capsule 100 at the top of the esophagus. The collar device may be configured similar to the collar 206 component of the external positioning system 200 described above without the track 204 attached. When it is time to release the imaging capsule 100 to begin imaging the esophagus, the external magnet can be lifted away from the patient, or de-energized in the case of an electromagnet. The collar device can also be used to capture and hold the imaging capsule 100 at the end of the procedure until it can be retrieved, for example using the magnetic probe 300 shown in FIG. 13. The collar device may include a sensor to detect when the endoscopy capsule 100 is captured and held by the external magnet. Optionally, a light or other indicator will show when the endoscopy capsule 100 is captured and held by the external magnet.

FIGS. 2A and 2B show a second embodiment of the apparatus of the invention where the external capsule positioning system 200 is fastened to the patient with a track 210 carrying an external magnet 212 positioned over the esophagus on the patient's dorsal or posterior side.

FIGS. 3 A and 3B show a third embodiment of the apparatus of the invention where the external capsule positioning system 200 includes an anterior track 204 carrying a first external magnet 202 and a posterior track 210 carrying a second external magnet 212. The anterior track 204 and posterior track 210 are positioned approximately parallel to one another by the collar 206 and the waist belt 208. The first external magnet 202 and the second external magnet 212 are preferably positioned with opposite poles of the magnets facing toward the patient. The use of two external magnets in this configuration helps to center the endoscopy capsule 100 within the esophagus and minimizes the bias of the endoscopy capsule 100 to follow the anterior or posterior wall of the esophagus. In addition to moving the endoscopy capsule 100 up and down the esophagus, the two external magnets can also be used to selectively aim the camera of the endoscopy capsule 100, as will be explained further below.

Preferably, the external capsule positioning system 200 is configured so that the first external magnet 202 and the second external magnet 212 will move synchronously up and down the torso of the patient. FIG. 4 is a schematic diagram of a synchronous drive mechanism for use in the apparatus of FIGS. 3 A and 3B. The first external magnet 202 and the second external magnet 212 are attached to a continuous cord or cable 214 that runs in a groove and/or over pulleys in the anterior track 204 and posterior track 210 and through a connecting member, such as the collar 206 or waist belt (not shown). The synchronous drive mechanism is configured so that, when the first external magnet 202 moves up or down, the second external magnet 212 moves up or down synchronously with it. The movement of the first external magnet 202 and the second external magnet 212 may be controlled manually, or the external capsule positioning system 200 may include an electric motor 216 configured to drive the cable 214. Other mechanisms, such as synchronized linear actuators, may be used to achieve synchronous movement of the first external magnet 202 and the second external magnet 212.

The electric motor 216 may include a rotary encoder for sensing the position of the first and second external magnets 202, 212 along the tracks 204, 210, which will correlate with the position of the endoscopy capsule 100 within the esophagus.

In FIGS. 1A-3B, the external magnets 202, 212 are shown riding on the outside of the anterior and posterior tracks 204, 210, which is particularly convenient for manual movement of the magnets. Alternatively, the external magnets 202, 212 may be disc-shaped or another low profile configuration so that they can be recessed into or enclosed within the anterior and posterior tracks 204,210 without sticking out beyond the outer surface of the tracks. This configuration would be particularly adaptable for use with an electrically driven embodiment of the external capsule positioning system 200.

FIG. 4 also shows a remote control feature that can be adapted for use with the various embodiments of the invention. The electric motor 216 is connected via a signal wire 222, or alternatively via an optional wireless transmitter/receiver 224, to a control actuator 220, such as a joystick, trackball, touch pad, computer mouse or any other potential user interface. Using the control actuator 220, the external magnets 202, 212 can be controlled to move up and down the anterior and posterior tracks 204, 210 to control the position of the endoscopy capsule 100 within the patient's esophagus. This provides tremendous convenience to the operator who can remotely control the position of the endoscopy capsule 100 while watching the images taken within the patient's esophagus on a monitor. The monitor may also provide a graphic display of the position of the endoscopy capsule 100 based on information from a rotary encoder within the electric motor 216 or another type of position sensor incorporated into the external capsule positioning system 200. It will be readily understood that the control actuator also has a transmitter/receiver (not shown) for transmitting/receiving information to/from transmitter/receiver 224. Further, although not shown, it will be readily understood that control actuator is coupled to a computer having a monitor wherein a software package is installed on the computer which is used along with viewing the monitor to control the movement of the external magnets 202, 212 as described above and infra.

FIG. 5 shows an endoscopy capsule 100 for use in the present invention. In this embodiment, the endoscopy capsule 100 has an external shape that is approximately ellipsoidal. The elongated ellipsoidal shape of the endoscopy capsule 100 tends to keep it in an approximately vertical orientation within the esophagus. In alternate embodiments, the endoscopy capsule 100 may have an external shape that is spherical or oblong, for example in the shape of an American football or

rugby football. A miniature imaging camera 102 for still and/or video images, such as a CCD camera, and a light source 104 are positioned at one end of the endoscopy capsule 100 looking outward through a lens 106. The light source 104 can be incandescent, fluorescent, chemoluminescent, a light emitting diode (LED) or a laser diode. The endoscopy capsule 100 also includes control circuitry, image transmitting and/or image storage circuitry and a power source, such as a battery, shown generally by reference number 108. The endoscopy capsule 100 includes a magnetically attracted element 110, which may be a permanent magnet, an electromagnet or a magnetically attracted ferritic material. By way of example, the endoscopy capsule 100 of FIG. 5 is shown with a magnetically attracted element 110 of ferritic material located at the upper end of the endoscopy capsule 100. The endoscopy capsule 100 is preferably swallowed with the imaging camera 102 aimed down the esophagus for effective imaging of the gastroesophageal junction.

FIG. 6 shows an endoscopy capsule 100 similar to the one in FIG. 5, except that it is configured 15 with one imaging camera 102 facing upward and another imaging camera 102 facing downward. Images taken from two directions may be helpful in identifying and diagnosing certain types of lesions. By way of example, the endoscopy capsule 100 of FIG. 6 is shown with a magnetically attracted element 110 made with a single bar magnet. This configuration of the magnetically attracted element 110 is useful for aiming the endoscopy capsule 100 within the esophagus, as 20 will be explained in greater detail below.

FIG. 7 shows a spherical endoscopy capsule 100 with a spherical imaging system. The spherical endoscopy capsule 100 of FIG. 7 is shown with a magnetically attracted element 110 of ferritic material located near the center of the sphere. Because of its spherical shape, the endoscopy capsule 100 will not have a preferred orientation within the esophagus. To compensate for this, the imaging system is configured to capture images completely surrounding the capsule. This can be accomplished using multiple cameras 102 and/or one or more cameras that have a fish eye or spherical view lens or similar optical system. The spherical images created by the imaging system can be stored and converted to more conventional image projections that are more easily interpreted by the user. The processed images can be panned left, right, up and down at any point in the esophagus because a full spherical image is stored for each exposure. Although the spherical endoscopy capsule 100 may rotate while descending through the esophagus, the orientation of the images can be determined relative to the proximal and distal esophagus, which will be apparent in the images and can be tracked using image recognition software.

FIGS. 8A and 8B show a spherical endoscopy capsule 100 that may be configured with one or more imaging cameras 102. Because of its spherical shape, the endoscopy capsule 100 will not have a preferred orientation within the esophagus. To orient the imaging cameras 102 in the desired direction, the spherical endoscopy capsule 100 has a magnetically attracted element 110 configured to have a dipole moment. This can be accomplished with the use of one or more permanent magnets or electromagnets. By way of example, the endoscopy capsule 100 of FIGS. 8A and 8B is shown with a magnetically attracted element 110 made with two permanent magnets arranged to provide a dipole moment about the center of the sphere. Alternatively, the magnetically attracted element 110 may be configured with a single bar magnet that passes through the center of the sphere. This configuration of the endoscopy capsule 100 is best used with the embodiment of the external capsule positioning system 200 shown in FIGS. 3 A and 3B. In FIG. 8A, the first external magnet 202 and the second external magnet 212 orient the spherical endoscopy capsule 100 so that the two imaging cameras 102 are aimed proximally and distally within the esophagus. In FIG. 8B, the first external magnet 202 and the second external magnet 212 have been rotated with respect to the patient's body to orient the spherical endoscopy capsule 100 with the two imaging cameras 102 aimed in a different desired direction. This feature can be used for close inspection of suspected lesions found in the esophagus.

In alternate embodiments, the endoscopy capsule 100 of FIGS. 8A and 8B may have an external shape that is an ellipsoid or other oblong shape, for example the shape of an American football or rugby football. In this case, the elongated shape of the endoscopy capsule 100 will tend to keep it in an approximately vertical orientation within the esophagus, except when the first and second external magnets 202, 212 are used to aim the endoscopy capsule 100 in a different orientation.

FIG. 9 shows an endoscopy capsule 100 configured with a rotatable inner capsule 112, having one or more imaging cameras 102, inside of a transparent outer capsule 114. The inner capsule 112 is rotatably suspended inside of the outer capsule 114, for example by filling the space between the inner and outer capsules 112, 114 with a liquid that provides neutral buoyancy or by mounting the inner capsule 112 on a gimbal mechanism or the like. The inner capsule 112 is preferably configured similar to the endoscopy capsule 100 of FIGS. 8 A and 8B so that it can be aimed in a desired direction within the esophagus, as described above. By way of example, the magnetically attracted element 110 is configured of two permanent magnets arranged to provide a dipole moment about the center of the sphere. The inner capsule 112 is preferably spherical when fluid suspension is used, but can be almost any shaped when a gimbal mechanism is used. The transparent outer capsule 114 can be spherical as shown or it can be configured as an ellipsoid or other convenient shape. The advantage of this embodiments of the endoscopy capsule 100 is that the inner capsule 112 can be rotated to aim the imaging cameras 102 without friction against the walls of the esophagus.

FIG. 10 shows an endoscopy capsule 100 with a selectively inflatable bladder or bladders 120. The bladder 120 can be selectively inflated and deflated by an inflation/deflation means 124 located within the endoscopy capsule 100. The inflation/deflation means 124 may operate using pressurized gas carried within the capsule, by a chemical reaction or by a miniature inflation/deflation pump within the capsule. The inflation/deflation means 124 may be controlled by signals, such as RF signals or magnetic signals, delivered from outside of the patient's body. The bladder 120 inflates approximately symmetrically around the endoscopy capsule 100 to contact the esophageal wall, for example to deliver a therapeutic treatment to the esophageal wall. Such therapeutic treatments could include cryogenic ablation, thermal ablation, RF ablation, ultrasonic ablation, laser ablation, phototherapy, radiation, brachytherapy, etc.

FIG. 11 shows an endoscopy capsule 100 with an asymmetric selectively inflatable bladder 122. The bladder 122 can be selectively inflated and deflated by an inflation/deflation means 126 located within the endoscopy capsule 100. The inflation/deflation means 126 may operate using 30 pressurized gas carried within the capsule, by a chemical reaction or by a miniature inflation/deflation pump within the capsule. The inflation/deflation means 126 may be controlled by signals, such as RF signals or magnetic signals, delivered from outside of the patient's body. When the bladder 122 inflates, the capsule 100 is pressed against the esophageal wall. The capsule 100 can deliver any of the therapeutic treatments to the esophageal wall discussed above and/or it can perform a diagnostic or therapeutic function that requires direct contact with the esophageal wall. For example, the capsule 100 can be configured to measure pH and/or temperature, inject medication, take biopsy samples or excise small polyps or other growths.

FIG. 12 shows an endoscopy capsule 100 with a selectively expandable structure 130. The selectively expandable structure 130 is the mechanical analog of the inflatable bladders of FIGS. 10 and 11 and can be configured to expand symmetrically or asymmetrically around the capsule 100. The selectively expandable structure 130 is configured with struts, hoops or other structures that can be activated with a shape memory material, with a microelectromechanical system (MEMS) or with pressurized chambers. An actuation means 132 for selectively expanding and contracting the structure 130 may be located within the endoscopy capsule 100. The actuation means 132 may be controlled by signals, such as RF signals or magnetic signals, delivered from outside of the patient's body. When the structure 130 expands, the structure 130 and/or capsule 100 is pressed against the esophageal wall. The capsule 100 can perform any of the diagnostic or therapeutic function discussed above.

Other possible features that may also be included in any of the embodiments of the endoscopy capsule 100 include:

The endoscopy capsule 100 may include means to deliver different wavelengths or spectra of light for different purposes. This can be accomplished by using different light sources 104 or by using a broad-spectrum light source 104 and one or more filters on the light source 104 and/or camera 102. For normal imaging, light in the visible range or white light is preferred. Other wavelengths can be used for different purposes instead of, or in addition to, normal imaging. For example, the endoscopy capsule 100 can be configured to do a spectroscopic examination, including chromoendoscopy, IR, UV, absorption, reflectance, transmission and/or fluorescence spectroscopy. Different CCD cameras 102 with different ranges of sensitivity may be used for different kinds of imaging or spectroscopy. Dyes may be applied to the esophageal wall to enhance imaging or spectroscopy. For example, the dye may be swallowed by the patient or it may be sprayed or injected by the endoscopy capsule 100.

Because it is controlled by the external magnets 202,212, the endoscopy capsule 100 can make multiple passes up and down the esophagus, alternating between normal imaging and spectroscopy by switching between different light sources or filters.

Alternatively, the endoscopy capsule 100 may be configured to perform more than one kind of imaging simultaneously. For example, by alternating white light and light of a different wavelength and gating the imaging signals in timing with the light sources, a normal image and a spectroscopic image can be created at the same time. This can be accomplished by using a plurality of light sources 104 or by using one light source 104 and different filters. The images may be still images or video images or a combination of the two. Computer software can be used to separate and/or to combine the two images for enhanced diagnosis of different kinds of lesions. The images from the two imaging modalities may be viewed separately, displayed side-by-side and/or superimposed on one another in real time and/or in recorded images in order to facilitate diagnosis and treatment of the tissues being imaged.

Alternatively or in addition, the endoscopy capsule 100 may be configured to perform ultrasonic imaging. Ultrasonic imaging can be used to examine and/or measure the esophagus and surrounding tissues. Ultrasonic imaging can also be used for transesophageal echocardiography with much less discomfort for the patient than current methods.

The endoscopy capsule 100 may operate entirely on power stored in a battery. Alternatively, the endoscopy capsule 100 may include means to charge the battery from the outside, for example using inductive coupling, photovoltaic charging, etc. This may be important for more energy-demanding applications, such as endoscopic imaging or delivering therapeutic energy over an extended period. Alternatively, a thin wire or cable may extend out of the patient's mouth from the endoscopy capsule 100 for supplying energy and/or recharging the battery.

Any of the embodiments of the endoscopy capsule 100 may configured to perform a diagnostic or therapeutic function, including cryogenic ablation, thermal ablation, RF ablation, ultrasonic ablation, laser ablation, phototherapy, radiation, brachytherapy, measurement of pH and/or temperature, injection of medication, and biopsy or excision of small polyps or other growths. Depending on the clinical indications, therapy may be delivered to a specific lesion or to a general region of the esophagus. For example, the endoscopy capsule 100 may include means to 10 activate a needle and push medication into a lesion or other area of the esophagus. The endoscopy capsule 100 may use an inflatable bladder or expandable structure to stabilize the capsule in position relative to an area to be treated as described above in connection with FIGS. 10-12. Alternatively or in addition, the endoscopy capsule 100 can be aimed and/or stabilized in position relative to an area to be treated using the first and/or second external magnets 202, 212 of the external capsule positioning system 200. The endoscopy capsule 100 can be controlled to perform the diagnostic and/or therapeutic functions by signals, such as RF signals or magnetic signals, delivered from outside of the patient's body.

Optionally, the endoscopy capsule 100 can be attached to a string or tether for retrieving the 20 capsule from the patient's mouth.

The current invention includes apparatus and methods for spectroscopic imaging in capsule endoscopy. The capsule endoscopy will use any of the above spectroscopic techniques or any other spectroscopic technique to visualize dyplastic and abnormal tissue. Since the capsule endoscopy can use a tracking system to enable localization or identifying the location of the capsule in the gastrointestinal tract, the current invention also describes a combination of the spectroscopic visualization with regular light visualization. For example alternation of regular (visible) light with the spectroscopic light will enable the endoscopy capsule to collect two separate images of the GI tract.

The capsule may or may not be connected to the outside with a cord or cable(s). If not connected to the outside, the capsule may transmit the images to the outside or store the images inside the capsule. The images may be saved as a movie/video or as separate frames. One option is to separate the regular images/movie from the spectroscopic images/movie. One option is to project those images/movies side-by-side to correlate the anatomical findings (regular light) to the pathological findings (spectroscopy). Another option is to use external means (such as GPS technology, imagines studies or others) to locate the capsule relative to the body in order to locate where the pathology is. The capsule may include other features such as biopsy and therapy capabilities. The device will also be able to mark special locations in the GI tract by injecting dye, spraying colors or any other possible technique in order to mark where the pathology was found for a later therapy.

An example of a spectroscopic imaging technique that can be used with the present invention is protoporphyrin IX fluorescence, which has been shown to be useful for identifying areas of high-grade dysplasia in Barrett's esophagus.

Another imaging technology that can be used in the present invention is radionuclide imaging, known also as nuclear medicine scanning, which is a method for localizing diseases of internal organs by injecting small amounts of a radioactive substance (isotope) into the bloodstream. The isotope collects in certain organs or tissues and a special camera is used to produce an image of the organ and detect areas of disease. Several different isotopes are used in radionuclide imaging, including technetium 99m, indium 111, thallium 201, iodine 123, iodine 131, Gallium 67, Samarium 153, Strontium 89, and Xenon 133.

Examples of radionuclide imaging techniques that can be used include: tumor-specific monoclonal antibody radioimmunoscintigraphy, an imaging technique that uses radioisotope labeled antibodies for identifying cancer cells; radioisotope labeled polyclonal antibodies for identifying inflammatory disease (for example, nonspecific polyclonal immunoglobulin G (IgG) has been shown to localized as well as specific antibodies for identifying inflammatory bowel disease); radioisotope labeled white blood cells (leukocytes) for identifying inflammatory disease; radioisotope labeled cytokines for imaging chronic inflammation.

Another example of radionuclide imaging technique that can be used is a red blood cell scan that is used to diagnose bleeding. In this example, the capsule will be able to sense the radionuclide material that is added to the red blood cells and to identify areas of internal bleeding in a much more sensitive way than the techniques employed currently.

The endoscopy capsule will be configured to include a radiation detector sensitive to the emissions of the radioisotope used. The radiation detector can be configured to produce static or moving images of the area scanned. The images are recorded within the endoscopy capsule and/or transmitted to a receiver outside the body. Alternatively, if high spatial resolution is not needed, the radiation detector can be configured to simply detect and record and/or transmit the level of radiation as the endoscopy capsule passes through the digestive tract.

The endoscopy capsule can be configured to alternate between the visible light imaging and radionuclide imaging so that images from the two imaging modalities can be analyzed and compared to localize pathological conditions. Alternatively, if the two imaging modalities chosen do not interfere with one another, the visible light imaging and radionuclide imaging can be conducted continuously and simultaneously.

The imaging modalities described herein can also be used in conjunction with a conventional optical endoscope or a video endoscope for visible light and/or spectroscopic imaging. For example, FIG. 14 illustrates a video endoscope 310 with an imaging capsule 100 mounted on the distal end. The imaging capsule 100 may be configured like any of the various embodiments of imaging capsules described herein. In particular, an imaging capsule 100 with two or more sources of illumination can be used for capturing both visible light and spectroscopic images of the internal anatomy. The imaging capsule 100 may be permanently or removably mounted to the distal end 312 of the endoscope 310. Images may be transmitted from the imaging capsule 100 by wireless transmission or through a cable in the endoscope 310. In various embodiments, the endoscope 310 may be a flexible endoscope, a robotically steerable endoscope or a rigid endoscope, depending upon the anatomy that is to be accessed and imaged using the device. If a conventional optical endoscope is used, an external imaging unit 316 containing the light source(s), imaging camera(s) and optional filter(s) can be mounted at the proximal end 314 of the endoscope 310 proximal to the optical imaging components of the endoscope. Another alternative is to place the light source(s) and optional filter(s) in an external imaging unit 316 and to place the imaging camera(s) at the distal end 312 of the endoscope 310, or vise versa.

The endoscope 310 can make multiple passes within the anatomy, alternating between normal visible light imaging and spectroscopy by switching between different light sources or filters in the imaging capsule 100 or the external imaging unit 316. Alternatively, visible light imaging and spectroscopic imaging may be performed simultaneously, for example, by alternating visible light and light of a different wavelength and gating the imaging signals in timing with the light sources. This can be accomplished by using a plurality of light sources 104 or by using one light source 104 and different filters, as described above. The images may be still images or video images or a combination of the two. Computer software can be used to separate and/or to combine the two images for enhanced diagnosis of different kinds of lesions. The images from the two imaging modalities may be viewed separately, displayed side-by-side and/or superimposed on one another in real time and/or in recorded images in order to facilitate diagnosis and treatment of the tissues being imaged.

Rather than physically moving a magnet or electromagnet along a track, the position of the endoscopy capsule within the patient's esophagus can be controlled by a series of independently addressable electromagnets positioned along a path to replicate the function of the moving magnet(s) in the capsule positioning systems described above. By way of example, FIGS. 15 A and 15B illustrate anterior and posterior views of another embodiment of an external capsule positioning system 200 for use in performing esophageal capsule endoscopy on a patient. The external capsule positioning system 200 includes an anterior strip 230 of electromagnets 232 and a posterior strip 234 of electromagnets 236 that are arranged approximately parallel to the patient's esophagus. The electromagnets 232, 236 are wired to be independently addressable so that the location, magnitude, direction and polarity of the electromagnetic field can be varied as desired. In a preferred embodiment, the anterior strip 230 of electromagnets 232 and the posterior strip 234 of electromagnets 236 are attached to a vest 238, or similar garment such as a shirt, jacket or apron, for fastening the external capsule positioning system 200 to the patient. Alternatively, a collar and belt, straps, adhesive tape or other attachment means may be used. Preferably a closure 240, such as a zipper, hook-and-loop fasteners, snaps, buckles, etc., is provided to facilitate donning the vest 238 and adjusting the fit. A well adjusted fit and the elasticity of the garment will help to keep the anterior strip 230 of electromagnets 232 and the posterior strip 234 of electromagnets 236 properly positioned over the esophagus and in good contact with the patient's body. Because the electromagnets 232, 236 do not have to be a continuous rigid structure, this embodiment of the external capsule positioning system 200 can be more flexible than the embodiments described above having a magnet sliding along a track. Greater flexibility allows the electromagnets 232, 236 to be mounted as close as possible to the esophagus for greater effectiveness.

The external capsule positioning system 200 can be configured with more than two strips of electromagnets. For example, FIGS. 16A and 16B illustrate anterior and posterior views of another embodiment of an external capsule positioning system 200 for use in performing esophageal capsule endoscopy on a patient. Two anterior strips 242, 244 of electromagnets 246, 248 and two posterior strips 250, 252 of electromagnets 254, 256 are attached to a vest 238, or similar garment. For example, the strips 242,244,250, 252 may be positioned 5 cm to the right and left side of the centerline in the front and back. The four strips 242, 244, 250, 252 of individually addressable electromagnets 246,248,254, 256 allow greater flexibility in aiming the endoscopy capsule 100 and/or moving it into contact with a selected area of the esophageal wall. Since the capsule can be approximated to the esophageal wall, biopsy specimens can be taken and/or diagnostic or therapeutic substances can be delivered by the capsule.

Preferably, the embodiments of FIGS. 15A, 15B, 16A and 16B include a remote control system that allows the position of the endoscopy capsule 100 within the patient's esophagus to be controlled remotely using to a control actuator 220, such as a joystick, trackball, touch pad, computer mouse or any other potential user interface. The control actuator 220 communicates with the external capsule positioning system 200 via a wireless transmitter/receiver 224, or alternatively via a signal wire. Using the control actuator 220, the anterior strip(s) of electromagnets and the posterior strip(s) of electromagnets can be controlled to move the endoscopy capsule 100 up and down within the patient's esophagus. This provides tremendous convenience to the operator who can remotely control the position of the endoscopy capsule 100 from a work station while watching the images taken within the patient's esophagus on a monitor. The monitor may also provide a graphic display of the position of the endoscopy capsule 100.

When used in conjunction with a spectroscopic imaging capsule, as described above, the remote control system will preferably also have the ability to remotely control the wavelength(s) of light that are used at any time during the examination. When needed, the spectroscopic imaging may be selected or the white light imaging may be selected, and if desired the two can be alternated quickly to provide the two images simultaneously.

The operator will have an option to activate one or more electromagnets at the same time in both the anterior strip(s) and the posterior strip(s). A combination of the two may give the best result. For example, energizing electromagnets with a North polarity facing the front of the patient and a South polarity facing the back of the patient will aim a capsule that has a North magnetic pole at its imaging end toward the back wall of the esophagus, whereas energizing only one or more electromagnets with a South polarity facing the back of the patient will tend to move the same capsule toward the posterior wall of the esophagus. It may also be desirable at times to energize the electromagnets with similar poles facing the front and back of the patient in order to urge the magnetic capsule up or down the esophagus without changing its orientation in the esophageal lumen.

The system may use a computer to calculate the relative forces and the exact location of the magnetic area on each one of the strips separately in order to generate the total force and its direction that will take the capsule to the exact location desired by the operator.

The operator may use a dedicated software that will enable him to show exactly where he wants to go and the software will do the calculations and will control the electromagnets. Similarly, dedicated software can be used control the motion of permanent magnets along a track or to control the motion, strength and polarity of electromagnets along a track in the embodiments of the invention described above.

If the operator desires to retrieve the capsule, the invention describes a capsule retriever that is inserted manually into the oropharynx and has a magnet at its end that can catch the capsule that was directed via the external magnet back into the oropharynx. This retriever can also have a mechanical lock that will hold the capsule once it is engaged. It will be readily understood that the computer may be coupled to the control actuator which may have a transmitter/receiver (or a signal wire) for communicating/controlling the external capsule positioning system. A monitor for viewing graphics showing the path of the endoscopy capsule and/or the external capsule is coupled to the computer. The graphics shown are generated by a software package running on the computer.

While the present invention has been described herein with respect to the exemplary embodiments and the best mode for practicing the invention, it will be apparent to one of ordinary skill in the art that many modifications, improvements and subcombinations of the various embodiments, adaptations and variations can be made to the invention without departing from the spirit and scope thereof. 

1. An endoscopic imaging apparatus, comprising: an ingestible endoscopy capsule including a magnetically attracted element, an external capsule positioning system including a plurality of selectively addressable electromagnets for positioning the endoscopy capsule within a patient.
 2. The endoscopic imaging apparatus of claim 1, wherein the magnetically attracted element of the endoscopy capsule comprises a permanent magnet.
 3. The endoscopic imaging apparatus of claim 1 where the magnetically attracted element of the endoscopy capsule comprises an electromagnet.
 4. The endoscopic imaging apparatus of claim 1, wherein the magnetically attracted element of the endoscopy capsule comprises a magnetically ferritic material.
 5. The endoscopic imaging apparatus of claim 1, wherein the external capsule positioning system is a strip of electromagnets where each of said electromagnets is wired to be independently addressable for moving the endoscopy capsule within the patient's anatomy.
 6. The endoscopic imaging apparatus of claim 5 wherein the external capsule positioning system further comprises a garment for fastening the strip of electromagnets to the patient in a position approximately parallel with the patient's esophagus.
 7. The endoscopic imaging apparatus of claim 6 where the garment is configured for fastening an anterior strip of electromagnets to the patient.
 8. The endoscopic imaging apparatus of claim 6 where the garment is configured for fastening a posterior strip of electromagnets to the patient.
 9. The endoscopic imaging apparatus of claim 1, wherein the external capsule positioning system comprises one anterior strip of independently addressable electromagnets one posterior strip of independently addressable electromagnets to move the endoscopy capsule along a desired path within the patient's anatomy.
 10. The endoscopic imaging apparatus' of claim 1 wherein the external capsule positioning system comprises at least two anterior strips of independently addressable electromagnets and at least two posterior strips of independently addressable electromagnets to move the endoscopy capsule along a desired path within the patient's anatomy.
 11. The endoscopic imaging apparatus of claim 1, wherein the endoscopy capsule includes a visible light imaging component and a spectroscopic imaging component.
 12. The endoscopic imaging apparatus of claim 1, wherein the endoscopy capsule includes an electronic memory for storing images within the capsule.
 13. The endoscopic imaging apparatus of claim 1, wherein the endoscopy capsule includes a transmitter for transmitting images to an external receiver.
 14. The endoscopic imaging apparatus of claim 1, wherein the external capsule positioning system further comprises a remote control system comprising a control actuator to control the selectively addressable electromagnets to move the endoscopy capsule up and down within the patient's esophagus.
 15. The endoscopic imaging apparatus of claim 14 where the control actuator communicates with the external capsule positioning system via a wireless transmitter/receiver.
 16. The endoscopic imaging apparatus of claim 14 where the control actuator communicates with the external capsule positioning system via a signal wire.
 17. The endoscopic imaging apparatus of claim 14 where images taken within the patient's esophagus is displayed on a monitor to allow an operator of the apparatus to view the images while remotely controlling the endoscopy capsule from a remote workstation.
 18. The endoscopic imaging apparatus of claim 14, wherein the endoscopy capsule is a spectroscopic imaging capsule and the actuator is capable of controlling remotely wavelengths of light used by the endoscopy capsule to selectively provide spectroscopic imaging or white light imaging alternatively or simultaneously.
 19. The endoscopic imaging apparatus of claim 14, wherein the external capsule positioning system is a strip of electromagnets each of which is wired to be independently addressable and the remote control system further comprises a computer to calculate relative forces and exact location of magnetic areas on each of the strip separately in order to generate force and direction on the endoscopy capsule to a location desired by an operator of the remote control system.
 20. The endoscopic imaging apparatus of claim 14, wherein the external capsule positioning system comprises an anterior strip of electromagnets and a posterior strip of electromagnets where each electromagnet is wired to be independently addressable and where an operator of the remote control system has an option to activate one or more the electromagnets with a North or South polarity where some of the activated electromagnets are positioned at the patient's front and other activated electromagnets are positioned at the patient's back to aim the endoscopy capsule at a desired direction.
 21. The endoscopic imaging apparatus of claim 20, wherein electromagnets with similar poles facing the front and the back of the patient are energized to urge the endoscopy capsule up or down the patient's esophagus without changing the capsule's orientation.
 22. The endoscopy imaging apparatus of claim 19 where the operator of the remote control system uses a dedicated software enabling the operator to show a desired destination of the endoscopy capsule and cause the software to control the electromagnets to move the endoscopy capsule to the desired location.
 23. An endoscopic imaging apparatus, comprising: an ingestible endoscopy capsule including a magnetically attracted element, and an external capsule positioning system including at least one magnet for positioning the endoscopy capsule within the patient and a track for moving the magnet along a predetermined path corresponding with a desired path for moving the endoscopy capsule within the patient's anatomy where the external capsule positioning system has a remote control system comprising a control actuator to control the at least one magnet via a signal wire or via a wireless transmitter/receiver to move the magnet up and down the track.
 24. The endoscopic imaging apparatus of claim 23 where the external capsule positioning system has an anterior track and a posterior track each of which has a magnet positioned therein and where each magnet is controlled by operation of the control actuator via a signal wire or via a wireless transmitter/receiver.
 25. The endoscopic imaging apparatus of claim 24 where the external capsule positioning system further comprises a computer on which dedicated software is installed to control each of the magnets' motion, strength and polarity along the magnet's track. 